New Tools Track Safety, Value in Medicine

The process for establishing an active drug safety surveillance system that can quickly detect and assess adverse events is emerging as a model for tapping third-party data to develop information on the performance of medical products and healthcare delivery. In demonstrating ways to link and analyze different data sources, FDA's emerging Sentinel System may be a "national resource for evidence development," says Mark McClellan, former FDA commissioner, now director of the Brookings Institute's Engelberg Center for Healthcare Reform.

Establishing Sentinel, as required by the FDA Amendments Act of 2007 (FDAAA), is a complex undertaking that involves linking up diverse databases and establishing standard analytical methods for evaluating safety signals. As a distributed network, Sentinel leaves patient health information with the data holders, an approach designed to ensure the privacy and security of personal health information. This approach now appears to have uses beyond safety surveillance—for comparative effectiveness research (CER), assessing quality of care, and supporting drug development by identifying patients for clinical trials and evaluating biomarkers.

New Claims Database

Leaders of the Sentinel Initiative discussed its larger impact at a January workshop organized by Brookings as well as at the Drug Information Association's pharmacovigilance conference. Rachel Behrman, associate director for medical policy in the Center for Drug Evaluation and Research (CDER), noted that FDA's collaborative experience with Sentinel may influence the shape of similar initiatives by other government agencies.

For example, the Department of Health and Human Services (HHS) is building a multipayer claims database (MPCD) to support comparative effectiveness research, as authorized and funded by the economic stimulus legislation of 2009. The plan is to build a "hybrid" system with a centralized administrative database on some 100 million individuals in Medicare and other health plans, plus a parallel distributed network component, similar to Sentinel, that can tap additional patient information held by health plans.

The HHS project also may incorporate data from states that have established their own MPCDs, primarily as cost-control strategies. About a dozen state initiatives are analyzing eligibility and claims data to track healthcare use and quality, and to uncover fraud and waste.

These systems currently tap into administrative and claims data, but the plan is to add clinical data in the future, at least for some patient cohorts. For now, Sentinel data partners may be asked to provide certain patient-level information if needed to confirm unclear findings, with that data stripped of patient identifiers before transmission.

Ultimately, a national interoperable electronic medical records system will feed patient-level information into all these information systems. With appropriate privacy protections, this will facilitate assessments of healthcare delivery, support biomedical research, and track medical care for many purposes. But because a comprehensive e-health system is still years away, HHS and FDA will continue to build systems that can assess specific healthcare issues through third-party data banks.

At the Brookings workshop, HHS assistant secretary for policy and evaluation Sherry Glied emphasized the need to coordinate the MCPD project with Sentinel, and CDER director Janet Woodcock similarly suggested that it's important to avoid "reinventing the wheel" with each initiative. Woodcock acknowledged that Sentinel is part of a broader effort to better use data to improve healthcare, and FDA, she said, "is willing to be a node" on these larger e-health information operations.

UnitedHealth Group medical affairs chief Reed Tuckson echoed those remarks, noting that health plans are receiving hundreds of requests for data from federal, state, intrastate, and demonstration projects. Tuckson agreed that these data initiatives can help improve healthcare and product safety, but noted that "data is expensive," and meeting all the requests costs a lot of money.